CLEVELAND, Ohio – September 12, 2016 — The U.S. Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for CLEVECORD™, a stem cell product (HPC, Cord Blood) derived from umbilical cord blood. Under this license, CCBC is authorized to manufacture CLEVECORD, for use in unrelated hematopoietic cell transplantation in patients with disorders affecting the hematopoietic system such as leukemia, lymphoma and immune system disorders.
“Obtaining FDA licensure for CLEVECORD is reflective of the Cleveland Cord Blood Center’s dedication to meeting the highest quality standards in the industry for distribution of our cord blood products to transplant centers throughout the U.S. and around the world,” said Wouter Van’t Hof, the CCBC’s Cord Blood Bank Director. “The ability to meet such standards is indicative of the commitment of our organization to providing high quality transplant options to patient populations that are underserved in hematopoietic transplantation. It also stages the pursuit of new life-saving and life-enhancing research and product development opportunities.”
The organization’s cord blood collections represent a diverse cross-section of donor ethnicity to support transplant needs, including patients in the underserved African-American community.
“It’s all about the possibility of saving lives,” explained Executive Director Marcie Finney. “Our high standards are implemented from the moment the baby’s cord blood is collected to the delivery of cord blood units to transplant centers. Up to 50% of parents giving birth in our partner hospitals donate their baby’s umbilical cord blood, a rate well above the national average. ”
Cleveland Cord Blood Center cord blood stem cell units are searched and accessed through registries, including the National Bone Marrow and Donor Program and Bone Marrow Donors Worldwide.
About the Cleveland Cord Blood Center (CCBC)
Launched in 2008, the CCBC collects, processes, stores, and distributes umbilical cord blood-derived stem cell units for use in hematopoietic progenitor cell therapy (HPC, Cord Blood) transplants and advanced research in cellular therapy. The organization was founded by Mary J Laughlin, MD, who performed one of the world’s first successful umbilical cord blood stem cell transplants on an adult leukemia patient in 1993. Located in Warrensville Heights, Ohio, CCBC is a public, not-for-profit 501 (c)(3) organization. Umbilical cord collection sites are located in Cleveland, Ohio and Atlanta, Ga. For more information, visit clevelandcordblood.org or call 1-866-922-3668.